Calcium Polycarbophil

Product NDC
58624-5003
11-digit product format
586245003
Labeler code
58624
Product ID
58624-5003_e7768a51-609b-4d3e-9864-b94ee9ccbdd9
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-12
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Polycarbophil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM POLYCARBOPHIL625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8F049NKY49
Rxcui308934

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58624-5003-1Calcium Polycarbophil90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58624-5003CALCIUM POLYCARBOPHIL TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.]7Current NDC, 1 package rows20250110_ee06868b-f741-8da2-e053-2a95a90a9772.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSNee06868b-f741-8da2-e053-2a95a90a97727
308934calcium polycarbophil 625 MG Oral TabletSCDee06868b-f741-8da2-e053-2a95a90a97727
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYee06868b-f741-8da2-e053-2a95a90a97727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58624-5003-15862450030190 TABLET, FILM COATED in 1 BOTTLE (58624-5003-1) 2023-04-12NoNoHistorical